Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

This study has been completed.

Sponsor:

Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT00246441

First Posted: October 31, 2005

Last Update Posted: December 2, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day

Placebo Comparator: 2

Placebo

Drug: Placebo

treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day.

Detailed Description:

Social anxiety disorder (also known as social phobia) is an Axis I anxiety disorder characterized by intense fear and avoidance of social or performance situations in which one might be scrutinized. Its onset is typically in the early teen years. It is the third most common mental disorder in the United States, exceeded in prevalence only by depression and alcoholism. Approximately 20% of the individuals with social anxiety disorder have alcohol problems. Anecdotal and empirical evidence suggests that alcohol is used by some socially anxious individuals to self-medicate anxiety symptoms, a practice that could lead to alcohol abuse and/or dependence. The proposed project further explores the self-medication hypothesis through the use of a double-blind, randomized, placebo-controlled clinical trial. Paroxetine (a selective serotonin reuptake inhibitor) is the drug to be used in the study. Individuals who drink alcohol to cope with social anxiety symptoms and who meet DSM-IV criteria for the dual-diagnoses of social anxiety disorder and alcohol use disorders will be enrolled in the trial. All individuals will be seeking treatment for social anxiety disorder. The treatment phase will last 16 weeks. Dosing will start at 20 mg/day (paroxetine or placebo) and will increase gradually to a maximum dose of 60 mg/day. Each week during treatment and at the end of the trial, assessments will be made with standard instruments to determine the effect of paroxetine (versus placebo) on social anxiety severity, alcohol use, and more specifically, the intentional use of alcohol to cope with social anxiety symptoms. Additionally, 6 month and 12 month follow-up interviews will be conducted. The overarching hypothesis is that because paroxetine will improve social anxiety severity, alcohol use and/or alcohol use for coping will also be reduced in the paroxetine-treated group.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Meets DSM-IV criteria for current social anxiety disorder

Reports social anxiety in most situations (generalized type).

Treatment seeking for relief of social anxiety.

Meets DSM-IV criteria for current alcohol use disorder

Reads at the 6th grade level or above

Endorses using alcohol to cope with social anxiety either "very often" or "always."

Liebowitz Social Anxiety Scale Total score (modified version) of at least 60

Endorses drinking at least 15 standard drinks in a typical 30 day period or reports drinking heavily (defined as greater-than-or-equal-to 4 standard drinks on one occasion for women; greater-than-or-equal-to 5 standard drinks on one occasion for men, respectively) on at least 2 days in a typical 30 day period.

Exclusion Criteria:

Abuse or dependence on drugs other than nicotine or marijuana in last 90 days

Current or past diagnosis of bipolar disorder or schizophrenia

Significant suicide risk as assessed by the SCID

Current use of psychotropic medications

Treatment seeking for alcohol problems

Any unstable medical condition that might interfere with safe participation in the trial

Elevated liver enzymes (3 x greater than normal levels)

History of adverse reaction to paroxetine

History of failure to respond to adequate trial or dose of paroxetine for social phobia (60 mg/day for at least 6 weeks)

History of heart problems or abnormal ECG recording

Pregnancy, nursing, or refusal to use effective birth control if sexually active and premenopausal

History of one or more alcohol detoxifications

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246441